510(k) K851251

AUTO/MANUAL TITANIUM HEMOCLIP LIGATING CLIP 527200 by Edward Weck, Inc. — Product Code FZP

K851251 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "AUTO/MANUAL TITANIUM HEMOCLIP LIGATING CLIP 527200". The FDA issued a decision of Substantially Equivalent on July 2, 1985. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. Edward Weck, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1985
Date Received
March 27, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type